Delaware News

Department of Justice announces record settlement with Eli Lilly in drug marketing case

Criminal Division | Department of Justice | Department of Justice Press Releases | Date Posted: Tuesday, October 7, 2008



Wilmington, DE – The Delaware Department of Justice announced today that Delaware has
reached a record $62 million dollar settlement with Eli Lilly and Company arising from alleged
improper marketing of the antipsychotic drug Zyprexa. The agreement, reached with 32 states and
the District of Columbia, is the largest ever multi-state consumer protection pharmaceutical
settlement.
“Today’s agreement protects Delaware’s consumers by ensuring that they benefit from full
disclosure when making pharmaceutical drug treatment decisions,” stated Fraud and Consumer
Protection Division Director Timothy Mullaney.
Delaware and the participating states allege that Eli Lilly engaged in unfair and deceptive
practices when it marketed Zyprexa for off-label uses and for failing to adequately disclose its
potential side effects to health care providers. In addition to its payments to the states, Eli Lilly will
change how it markets Zyprexa and cease promoting its “off-label” uses, which are not approved by
the U.S. Food and Drug Administration (FDA). The Delaware Consumer Protection Fund will
receive $966,000.
Zyprexa, the brand name for the prescription drug olanzapine, was first marketed in 1996 for
use in adults with schizophrenia. Since then the FDA has also approved its use for the treatment of
bipolar disorder. Zyprexa belongs to a class of drugs, traditionally used to treat schizophrenia, that
were thought to be less likely to produce symptoms such as those seen in Parkinson’s disease and in
motion disorders. While they may reduce the risk of these symptoms, these drugs also produce
dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular
complications, and an increased risk of mortality in elderly patients with dementia. Zyprexa has
been associated with a high risk of weight gain, hyperglycemia, and diabetes.
In 2001, Eli Lilly began to aggressive market Zyprexa for a number of off-label uses,
including for children, elderly patients suffering from dementia, and the treatment of symptoms
rather than diagnosed conditions. While physicians may prescribe drugs for off-label uses,
pharmaceutical manufacturers are prohibited by law from marketing their products for off-label
uses.
Under today’s agreement, for six years beyond the patent term for Zyprexa Eli Lilly will,
among other things:
• Only provide product samples of Zyprexa to a health care provider whose clinical practice is
consistent with its current labeling
• Not promote Zyprexa for selected symptoms of the FDA-approved diagnoses unless disclosures
are made regarding the approved diagnoses
• Not use in a promotional manner article reprints containing more than an incidental reference to
off-label information regarding Zyprexa
• Require its medical staff, rather than its marketing staff, to be responsible for developing and
approving the medical content for all medical letters and medical references regarding Zyprexa
• Contractually require continuing medical education providers to disclose Eli Lilly’s financial
support of their programs and any financial relationship with faculty and speakers
• Provide each Attorney General participating in today’s agreement with a list of health care
provider promotional speakers and consultants who Eli Lilly paid more than $100 for promotional
speaking and/or consulting
# # #

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Department of Justice announces record settlement with Eli Lilly in drug marketing case

Criminal Division | Department of Justice | Department of Justice Press Releases | Date Posted: Tuesday, October 7, 2008



Wilmington, DE – The Delaware Department of Justice announced today that Delaware has
reached a record $62 million dollar settlement with Eli Lilly and Company arising from alleged
improper marketing of the antipsychotic drug Zyprexa. The agreement, reached with 32 states and
the District of Columbia, is the largest ever multi-state consumer protection pharmaceutical
settlement.
“Today’s agreement protects Delaware’s consumers by ensuring that they benefit from full
disclosure when making pharmaceutical drug treatment decisions,” stated Fraud and Consumer
Protection Division Director Timothy Mullaney.
Delaware and the participating states allege that Eli Lilly engaged in unfair and deceptive
practices when it marketed Zyprexa for off-label uses and for failing to adequately disclose its
potential side effects to health care providers. In addition to its payments to the states, Eli Lilly will
change how it markets Zyprexa and cease promoting its “off-label” uses, which are not approved by
the U.S. Food and Drug Administration (FDA). The Delaware Consumer Protection Fund will
receive $966,000.
Zyprexa, the brand name for the prescription drug olanzapine, was first marketed in 1996 for
use in adults with schizophrenia. Since then the FDA has also approved its use for the treatment of
bipolar disorder. Zyprexa belongs to a class of drugs, traditionally used to treat schizophrenia, that
were thought to be less likely to produce symptoms such as those seen in Parkinson’s disease and in
motion disorders. While they may reduce the risk of these symptoms, these drugs also produce
dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular
complications, and an increased risk of mortality in elderly patients with dementia. Zyprexa has
been associated with a high risk of weight gain, hyperglycemia, and diabetes.
In 2001, Eli Lilly began to aggressive market Zyprexa for a number of off-label uses,
including for children, elderly patients suffering from dementia, and the treatment of symptoms
rather than diagnosed conditions. While physicians may prescribe drugs for off-label uses,
pharmaceutical manufacturers are prohibited by law from marketing their products for off-label
uses.
Under today’s agreement, for six years beyond the patent term for Zyprexa Eli Lilly will,
among other things:
• Only provide product samples of Zyprexa to a health care provider whose clinical practice is
consistent with its current labeling
• Not promote Zyprexa for selected symptoms of the FDA-approved diagnoses unless disclosures
are made regarding the approved diagnoses
• Not use in a promotional manner article reprints containing more than an incidental reference to
off-label information regarding Zyprexa
• Require its medical staff, rather than its marketing staff, to be responsible for developing and
approving the medical content for all medical letters and medical references regarding Zyprexa
• Contractually require continuing medical education providers to disclose Eli Lilly’s financial
support of their programs and any financial relationship with faculty and speakers
• Provide each Attorney General participating in today’s agreement with a list of health care
provider promotional speakers and consultants who Eli Lilly paid more than $100 for promotional
speaking and/or consulting
# # #

image_printPrint


Graphic that represents delaware news on a mobile phone

Keep up to date by receiving a daily digest email, around noon, of current news release posts from state agencies on news.delaware.gov.

Here you can subscribe to future news updates.